We are looking for:
RSM (Level II)
PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.
Remote Site Monitoring and Management (RSMM) blends on and off-site monitoring functions, providing efficiency to our clients. The RSMM group provides global time zone coverage and optimizes technology. Working in the RSMM group, you will contribute directly to PPD's strategy to bend the time and cost curve of drug development by providing adaptive and intelligent monitoring services to our clients.
As a Remote Site Monitor (RSM), you will use a variety of tools and technologies to review study data. You will interact with study sites via phone, supporting the site teams and monitoring subject enrollment for the study. As a RSM you embody ethical research and business conduct, ensuring we never compromise quality or patient safety.
- Remotely reviews EDC (with or without source verification, depending on local practice and regulations). Performs source data verification from web-based sources where possible, and in compliance with local laws
- Writes, follows and resolves clinical queries and issues
- Remotely reviews drug accountability log
- Conducts and documents site management contacts according to the monitoring plan
- Evaluates PI oversight (e.g., protocol adherence), subject safety and study processes in order to assess site’s ability to conduct study
- Provides refresher training, follows up on outstanding administrative needs (e.g., outstanding/updated regulatory documents), assists with regulatory reviews, as requested, updates CTMS with site contact changes and maintain vendor tracker
- Reviews and appropriately escalates site key risk/performance/quality indicators (KRI, KPI, KQI [e.g., early termination and screen-fail rates, average number of open findings, etc.]), ad-hoc clinical listings review, tracks and trends violations and deviations, ensures visits occurred per the MP, site status, enrollment, CRF status and SAE follow up
- Provides trial status tracking and progress update reports to CTM as required
- Ensures study systems are updated per agreed study conventions (e.g., Clinical Trial Management System – CTMS)
- Liaises with CRA to promptly collect documents, reviews data points, findings from EDC and file reviews, etc.
- Conducts remote investigations into site performance issues at the directive of the CTM
- Assists in ensuring audit ready files. Contributes to company, client, and federal/local regulatory requirements/audit responses as needed
PPD offers award winning structured training programs, PPD was named to Training magazine's Training Top 125 list, a culture that supports meaningful and challenging work and a competitive compensation and benefits package including generous PTO and unique benefits like pet insurance, MDLive Telemedicine and much more!
Grow within the RSM career path as a Senior or Principal RSM, develop into a Clinical Research Associate, or move into other roles or departments within Global Clinical Development.
To learn how PPD can advance your career, apply now!
What To Expect Next
We look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.
Education and Experience:
- Bachelor’s Degree in a science-related field or relevant/equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities
- Prior clinical research experience ~ 1-2 years as well as knowledge of clinical monitoring through classwork/training that provides the required knowledge skills and abilities. In some cases, previous experience in a clinical environment where experience is gained in clinical trials, data management, medical terminology, medical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered
- Prefer individuals who aspire to advance into a CRA role
Knowledge, Skills, and Abilities:
- Basic medical/therapeutic area knowledge and understanding of medical terminology
- Ability to attain and maintain a working knowledge of FDA and/or local regulation and guidelines, ICH GCPs and PPD procedural documents
- Ability to successfully complete PPD’s Clinical Foundation Training Program (CFP)
- Ability to evaluate medical research data
- Ability to advise, counsel, and motivate investigational sites
- Effective oral and written communication skills with the ability to communicate effectively with medical personnel
- Excellent interpersonal and customer service skills
- Good organizational and time management skills
- Proven flexibility and adaptability
- Strong attention to detail
- Ability to work in a team or independently, as required
- Good computer skills with good knowledge of MS Office (Word, Excel, PowerPoint) and the ability to learn appropriate software
- Ability to extract pertinent information from all study documents, such as protocols, electronic study data systems, CTMS and dashboards
- Excellent English language and grammar skills
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner
- Able to work upright and stationary for typical working hours
- Ability to use and learn standard office equipment and technology with proficiency
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities
- May require travel. (Recruiter will provide more details)
Deadline for applications: 20.10.2019.